UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023570 |
|---|---|
| Receipt number | R000027147 |
| Scientific Title | Study on the efficacy and safety of titanium bridge for the adductor type spasmodic dysphonia |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2022/09/16 09:25:29 |
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Basic information
Public title
Study on the efficacy and safety of titanium bridge for the adductor type spasmodic dysphonia
Acronym
Study on the efficacy and safety of titanium bridge for the adductor type spasmodic dysphonia
Scientific Title
Study on the efficacy and safety of titanium bridge for the adductor type spasmodic dysphonia
Scientific Title:Acronym
Study on the efficacy and safety of titanium bridge for the adductor type spasmodic dysphonia
Region
| Japan |
Condition
Condition
Adductor type spasmodic dysphonia
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose is to validate the safety and efficacy of more breaking difficult titanium bridge
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of change before and after surgery of VHI-10
Preoperative and postoperative 13 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Thyroplasty type 2 using a titanium bridge
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients specialist of Japan Otolaryngology Society certification was diagnosed of Adductor type spasmodic dysphonia
2.Patients effort of utterance or voice interruption of more than 1 year
subjective or objective
3.90-year-old following of patients from 20 years of age on consent acquisition date
4.Document consent at the free will of the patients can be obtained
Key exclusion criteria
1.Dysphagia, Laryngeal paralysis or Organic lesion in the vocal cord
2.Patients with serious complications
3.Patients with a history of mental illness, mental disorders, intellectual disability, alcoholism and drug abuse in need of such treatment.
4.Hypersensitivity history with respect to pure titanium
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yorihisa Orita |
Organization
kumamotoUniversityHospital
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
Address
1-1-1, Honjo Chuo-ku, Kumamoto-shi Kumamoto, Japan
TEL
096-373-5255
jibika-ikyoku@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kouhei Nishimoto |
Organization
kumamotoUniversityHospital
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
Address
1-1-1, Honjo Chuo-ku, Kumamoto-shi Kumamoto, Japan
TEL
096-373-5255
Homepage URL
jibika-ikyoku@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Otolaryngology-Head and Neck SurgerykumamotoUniversityHospital
Institute
Department
Personal name
Funding Source
Organization
Department of Otolaryngology-Head and Neck SurgerykumamotoUniversityHospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 09 | Day |
Last modified on
| 2022 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027147
